Trigeminal Neuralgia (TN)NCT06998420
Developing a Clinical Prediction Model for Adverse Outcomes in Percutaneous Trigeminal Ganglion Balloon Compression
An observational study of Trigeminal Neuralgia (TN), run by Affiliated Hospital of Nantong University at 1 site in China.
Trial summary
This clinical study aims to investigate adverse outcomes following percutaneous balloon compression (PBC) of the trigeminal ganglion, establish a predictive model, and assess the probability of postoperative complications.The main question it aims to answer is: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trigeminal Neuralgia (TN)
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2022to 28 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent PCGG surgery at the Pain Department of Affiliated Hospital of Nantong University between 2022 and 2024 and were willing to participate in postoperative follow-up were selected as the study subjects.
Who may be able to join
- Diagnosed with primary trigeminal neuralgia and underwent PBCG at the Pain Department of Affiliated Hospital of Nantong University
- Age ≥18 years
- Willing to complete postoperative follow-up
Who cannot join
- Secondary trigeminal neuralgia (e.g., tumor compression, multiple sclerosis)
- Previous interventional treatments for trigeminal neuralgia
- Incomplete follow-up data
- General anesthesia contraindications or significant dysfunction of major organs (cardiac, pulmonary, hepatic, renal) or severe neurological impairment
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Hospital of Nantong University
Nantong, Jiangsu, 211600
About this study
Official title: Construction of a Clinical Prediction Model for Poor Prognosis Following Percutaneous Balloon Compression of the Trigeminal Ganglion
This clinical study aims to investigate adverse outcomes following percutaneous balloon compression (PBC) of the trigeminal ganglion, establish a predictive model, and assess the probability of postoperative complications.The main question it aims to answer is:
- What factors are associated with adverse postoperative outcomes?
- What is the occurrence probability of different types of adverse outcomes? The study will record patients' demographic and clinical characteristics, laboratory test results, and conduct follow-ups at 3, 6, and 12 months postoperatively.
- Conditions
- Trigeminal Neuralgia (TN)
- Keywords
- Trigeminal neuralgia, PCGG, poor prognosis, Clinical Prediction Model
- Medical subject headings
- Trigeminal Neuralgia
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain recurrence (BNI≥Ⅲ)
BNI Pain Intensity Scale Score:
I:No pain,no medication II:Occasional pain,not requiring medication III:Some pain,adequately controlled with medication IV:Some pain,not adequately controlled with medication V:Severe pain/no pain relief
Measured: Follow-up timepoints: 3, 6, and 12 months postoperatively (final determination based on preliminary observation endpoints)
Severe sensory impairment (facial numbness with BNI sensory score ≥ Grade III)
BNI Pain Intensity Scale Score:
I:No pain,no medication II:Occasional pain,not requiring medication III:Some pain,adequately controlled with medication IV:Some pain,not adequately controlled with medication V:Severe pain/no pain relief
Measured: 3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints).
Masticatory dysfunction (bite force reduction ≥50% or subjective weakness)
Measured: 3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints).
Secondary outcomes (4)
Mild sensory abnormalities (BNI sensory score Grade II)
BNI Pain Intensity Scale Score:
I:No pain,no medication II:Occasional pain,not requiring medication III:Some pain,adequately controlled with medication IV:Some pain,not adequately controlled with medication V:Severe pain/no pain relief
Measured: 3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints).
Diplopia or hearing loss (rare complications to be recorded)
Measured: 3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints).
Postoperative infection (puncture site/intracranial)
Measured: 3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints).
Psychological status (change in HADS score)
he HADS (Hospital Anxiety and Depression Scale) is a self-assessment questionnaire used to screen for anxiety (HADS-A) and depression (HADS-D) in patients, with each subscale ranging from 0 (no symptoms) to 21 (severe symptoms). A score ≥8 on either subscale suggests clinically significant symptoms.
Key features:
14 items (7 for anxiety, 7 for depression)
Simple \& fast (takes ~5 min)
Designed for non-psychiatric medical settings
Example scoring:
0-7: Normal
8-10: Mild
11-14: Moderate
15-21: Severe
Measured: 3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start10 Feb 2022
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigeminal Neuralgia (TN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998420
- Sponsor's protocol ID
- 2024-K098-01
- Status last verified
- Feb 2025
- First submitted
- 8 May 2025
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of a Clinical Prediction Model for Poor Prognosis Following Percutaneous Balloon Compression of the Trigeminal Ganglion
- ClinicalTrials.gov ID
- NCT06998420
- Acronym / sponsor ID
- 2024-K098-01
- Conditions
- Trigeminal Neuralgia (TN)
- Keywords
- Trigeminal neuralgia, PCGG, poor prognosis, Clinical Prediction Model
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical study aims to investigate adverse outcomes following percutaneous balloon compression (PBC) of the trigeminal ganglion, establish a predictive model, and assess the probability of postoperative complications.The main question it aims to answer is:
- What factors are associated with adverse postoperative outcomes?
- What is the occurrence probability of different types of adverse outcomes? The study will record patients' demographic and clinical characteristics, laboratory test results, and conduct follow-ups at 3, 6, and 12 months postoperatively.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent PCGG surgery at the Pain Department of Affiliated Hospital of Nantong University between 2022 and 2024 and were willing to participate in postoperative follow-up were selected as the study subjects.
Key inclusion criteria (3 listed)
- Diagnosed with primary trigeminal neuralgia and underwent PBCG at the Pain Department of Affiliated Hospital of Nantong University
- Age ≥18 years
- Willing to complete postoperative follow-up
Key exclusion criteria (4 listed)
- Secondary trigeminal neuralgia (e.g., tumor compression, multiple sclerosis)
- Previous interventional treatments for trigeminal neuralgia
- Incomplete follow-up data
- General anesthesia contraindications or significant dysfunction of major organs (cardiac, pulmonary, hepatic, renal) or severe neurological impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain recurrence (BNI≥Ⅲ)
Time frame: Follow-up timepoints: 3, 6, and 12 months postoperatively (final determination based on preliminary observation endpoints)
BNI Pain Intensity Scale Score: I:No pain,no medication II:Occasional pain,not requiring medication III:Some pain,adequately controlled with medication IV:Some pain,not adequately controlled with medication V:Severe pain/no pain relief
Severe sensory impairment (facial numbness with BNI sensory score ≥ Grade III)
Time frame: 3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints).
BNI Pain Intensity Scale Score: I:No pain,no medication II:Occasional pain,not requiring medication III:Some pain,adequately controlled with medication IV:Some pain,not adequately controlled with medication V:Severe pain/no pain relief
Masticatory dysfunction (bite force reduction ≥50% or subjective weakness)
Time frame: 3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints).
4 secondary outcomes
Mild sensory abnormalities (BNI sensory score Grade II)
Time frame: 3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints).
Diplopia or hearing loss (rare complications to be recorded)
Time frame: 3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints).
Postoperative infection (puncture site/intracranial)
Time frame: 3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints).
Psychological status (change in HADS score)
Time frame: 3 months, 6 months, and 12 months postoperatively (determined based on prior observation endpoints).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trigeminal Neuralgia (TN), run by Affiliated Hospital of Nantong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain recurrence (BNI≥Ⅲ) (time frame: Follow-up timepoints: 3, 6, and 12 months postoperatively (final determination based on preliminary observation endpoints)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.